Palatability of a Novel Oral Formulation of Prednsione
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Palatability of a new oral formulation of prednisone
研究概览
简要总结
Prednisone solution USP (5mg/5mL), is the most commonly prescribed formulation of prednisone to pediatric and adult patients. The rationale for this study is that palatability is the most important determinant of pediatric patient compliance, and therefore, it is critical that the Orbis formulation be perceived as significantly more palatable compared to today's commercially available products in order to warrant further development of the TP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 32 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18 to 32 years, male and female who are healthy at the time of study
- •can demonstrate holding 10 mL of apple juice in mouth for 5 seconds without swallowing and then expectorate contents into a cup
- •demonstrate ability to complete study questionnaire
排除标准
- •history of smoking or using any tobacco products
- •previous history of taste disturbance
- •any condition or dietary habit known to interfere with the sense of smell and taste
- •any structural or functional abnormality of the upper gastrointestinal tract
- •ingestion of any medication or nutritional supplement (with exception of acetaminophen tablets or capsules) in a 48 hour period prior to study
- •history of any significant illness within the two weeks prior to study
- •history of autonomic dysfunction, bronchospastic disease or atopic allergy
- •known hypersensitivity (ie., allergic reaction) to any drug, food coloring agent or artificial sweetener
- •any history of participating in a clinical trial of a drug or device within a 30 day period from the time of study
- •brushing of the teeth, usage of mouthwash, and or oral ingestion of any substance within two hours of receipt of the initial test article and
- •inability to speak and/or read English at a grade 10 level
结局指标
主要结局
Palatability of a new oral formulation of prednisone
时间窗: Immediately
We will create optimized shelf-stable prednisone microcapsules designed for complete taste-masking followed by immediate release in the stomach. Release characteristics of the TP will be compared to a pharmaceutical grade formulation of prednisone. Milestone: Microencapsulated prednisone that: (i) shows less than 10% coefficient of variance (CV) in the in vitro release profile between fresh and 4-week, 40°C stability-exposed samples while maintaining (ii) maximum of 5% total drug release during the initial 2 minutes and (iii) \>90% release within 30 minutes. N.B. This Specific Aim will be accomplished in the laboratories of Orbis Biosciences, Inc. Upon meeting all milestones associated with this SA, Orbis Biosciences will produce, in accordance with Good Laboratory and Manufacturing Principles, a single batch of TP suitable for use in accomplish SA2.
次要结局
- Evaluation of the TP for the organoleptic properties of taste, mouth-feel and aroma in healthy adults compared to the reference product (RP).(Immediately)
研究者
Greg Kearns
Senior Vice President and Chief Research Officer
Arkansas Children's Hospital Research Institute